K062638 is an FDA 510(k) clearance for the TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS, a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Procter & Gamble Co. (Cincinnati, US). The FDA issued a Cleared decision on November 22, 2006, 78 days after receiving the submission on September 5, 2006. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.
| 510(k) Number | K062638 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 05, 2006 |
| Decision Date | November 22, 2006 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HEB — Tampon, Menstrual, Unscented |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5470 |
| Definition | An Unscented Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge. |